Ultrasound System 1300 is an AI-enabled medical device from BK Medical Aps, listed by FDA (510(k), K231764) with a decision date of 2023-10-23. Review panel: Radiology.
| FDA submission number | K231764 |
|---|---|
| Pathway | 510(k) |
| Company | BK Medical Aps |
| Review panel (specialty) | Radiology |
| FDA decision date | 2023-10-23 |
| Decision | Substantially Equivalent |
| Product code | IYN |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Device class | 2 |
| Regulation number | 892.1550 |
| Review time (calendar days) | 129 |
| Applicant country | DK |
Official FDA database record · FDA AI-enabled device list
All Radiology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.